(55 days)
The ActiveCare+S.F.T.® and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopedic surgery procedures e.g total joint (hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment and can be provided directly to the patient for home use.
These devices are indicated for use in:
- . Preventing Deep Vein Thrombosis (DVT)
- Diminishing post-operative pain and swelling
- Reducing wound healing time
- Patients at risk for deep vein thrombosis (DVT) and related pulmonary embolism (PE) ● (Venous Thromboembolism (VTE))
- Treatment of venous stasis ●
- Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
- Enhancing blood circulation
- Treatment of chronic venous insufficiency ●
- Reducing edema ●
The ActiveCare+S.F.T. and ActiveCare+DTx® Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.
In addition, the ActiveCare+DTx® System can detect hemodynamic changes in venous blood flow.
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are prescriptive, portable, sequential, intermittent pneumatic compression devices designed to apply sequential compression to the lower limb. The systems include a rechargeable battery powered option (in addition to an AC/DC adapter) allowing full patient mobility and ease of use. The control units of the Systems provide the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the thigh - single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
The ActiveCare+S.F.T. and ActiveCare+DTx Systems are intended to provide continuous monitoring of each patient's venous phasic blood flow on a real time basis so that the timing of external compression is in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow.
In addition, the ActiveCare+DTx System can detect hemodynamic changes that may be indicative of the development of a venous blood flow obstruction event in the treated patient's limbs. The ActiveCare+DTx is not a diagnostic tool.
The provided text is a 510(k) summary for the ActiveCare+S.F.T. and ActiveCare+DTx Systems. It describes the device, its intended use, and states its substantial equivalence to a previously cleared device (K142728). However, it does not contain the specific details about acceptance criteria or a dedicated study demonstrating the device's performance against such criteria in the manner requested.
The "Performance Data" section mentions a "Human Factors and Usability Study" to validate usability for direct-to-home use, and states that its results "substantiated the acceptability of the risks identified during the risk assessment activities." It also lists other referenced testing such as "Electrical Safety, Electromagnetic Compatibility, Usability/Environmental, Software Validation, Internal testing and Risk Analysis."
Despite these mentions of testing, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for the test set ground truth.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Details on standalone (algorithm only) performance.
- The type of ground truth used (e.g., pathology, outcomes data) for clinical performance.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use and technological characteristics, rather than detailing a de novo performance study with specific metrics and ground truth. The listed "performance data" appears to refer more to safety and general usability testing rather than a clinical effectiveness study against predefined acceptance criteria for its therapeutic claims (e.g., preventing DVT, reducing edema).
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).